Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 1 of 150 PageID #: 9259
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`v.
`
`
`AMGEN INC.,
`
`Defendant and Counterclaim Plaintiff.
`
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 18-924-CFC
`
`C.A. No. 18-1363-CFC
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD,
`
`Defendant and Counterclaim Plaintiff.
`
`
`
`JOINT CLAIM CONSTRUCTION BRIEF
`
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 2 of 150 PageID #: 9260
`
`TABLE OF CONTENTS
`
`
`Page
`
`AGREED-UPON CONSTRUCTIONS ..................................................................... 1
`
`DISPUTED CONSTRUCTIONS .............................................................................. 2
`
`I.
`
`U.S. PATENT NOS. 6,627,196, 7,371,379, AND 10,160,811 ....................... 3
`
`1.
`
`2.
`
`Plaintiffs’ Introduction ................................................................ 3
`
`Defendants’ Introduction ............................................................ 4
`
`A.
`
`“An Initial Dose” (’196 Claims 11, 22; ’379 Claims 11, 21;
`’811 Claims 6, 7) ................................................................................... 4
`
`1.
`
`2.
`
`Plaintiffs’ Opening Position ........................................................ 4
`
`Defendants’ Answering Position ................................................ 6
`
`a.
`
`Amgen’s Answering Position ........................................... 6
`
`i.
`
`ii.
`
`“An initial dose” means “the first dose.” ............... 7
`
`The specification distinguishes between (1)
`“an initial dose” and (2) “initial doses” or
`“series of doses.” .................................................... 9
`
`iii. Amgen’s construction is tied to the asserted
`claims, which cover only the single initial
`dose embodiment. .................................................11
`
`iv.
`
`v.
`
`Claim 16 affirms the distinction between “an
`initial dose” and “plurality of initial doses.” ........12
`
`Extrinsic evidence confirms Amgen’s
`construction. .........................................................14
`i
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 3 of 150 PageID #: 9261
`
`vi. Genentech’s construction is unworkable. ............15
`
`b.
`
`Samsung’s Answering Position ......................................16
`
`3.
`
`Plaintiffs’ Reply Position ..........................................................19
`
`a.
`
`Defendants’ Construction Of “An Initial Dose” Is
`Inconsistent With The Intrinsic Evidence. .....................19
`
`i.
`
`ii.
`
`The Intrinsic Record Makes Clear That “An
`Initial Dose” Can Be A Plurality Of Doses. .........20
`
`The Intrinsic Record Does Not Require “An
`Initial Dose” To Be A “First Dose.” ....................23
`
`Extrinsic Evidence Does Not Support Amgen’s
`Construction Of “An Initial Dose.” ................................24
`
`Defendants’ Arguments Regarding Indefiniteness
`Are Flawed And Premature. ...........................................26
`
`Samsung’s Construction Of “An Initial Dose”
`Impermissibly Narrows The Claims To One
`Embodiment. ...................................................................26
`
`b.
`
`c.
`
`d.
`
`4.
`
`Defendants’ Sur-Reply Position ...............................................27
`
`a.
`
`Amgen’s Sur-Reply Position ..........................................27
`
`i.
`
`ii.
`
`Genentech’s construction ignores the
`specification’s teaching of two distinct
`alternatives ............................................................28
`
`“Initial dose” is synonymous with “first
`dose” .....................................................................30
`
`iii. Genentech did not counter Amgen’s
`extrinsic evidence .................................................31
`
`iv. Genentech does not address indefiniteness
`
`
`
`ii
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 4 of 150 PageID #: 9262
`
`problems caused by its construction ....................32
`
`b.
`
`Samsung’s Sur-Reply Position .......................................33
`
`II.
`
`U.S. PATENT NOS. 7,993,834 AND 8,076,066 ..........................................34
`
`1.
`
`2.
`
`Plaintiffs’ Introduction ..............................................................34
`
`Defendants’ Introduction ..........................................................35
`
`A.
`
`“A Method For Increasing Likelihood Of Effectiveness Of
`Breast Cancer Treatment With Humanized Anti-ErbB2
`Antibody huMAb4D5-8” (’834 Claims 2, 5) ......................................38
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ......................................................39
`
`Defendants’ Answering Position ..............................................40
`
`a.
`
`b.
`
`The preamble of the ’834 patent renders the claims
`indefinite .........................................................................40
`
`Genentech’s proposed construction does not
`resolve indefiniteness .....................................................42
`
`Plaintiffs’ Reply Position ..........................................................43
`
`Defendants’ Sur-Reply Position ...............................................48
`
`B.
`
`“Wherein The Patient’s Cancer Cells Express HER2 At A 0 Or
`1+ Level By Immunohistochemistry” (’066 Claims 2, 6) ..................49
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ......................................................49
`
`Amgen’s Answering Position ...................................................51
`
`Plaintiffs’ Reply Position ..........................................................56
`
`Amgen’s Sur-Reply Position ....................................................59
`
`III. U.S. PATENT NO. 8,574,869 .......................................................................61
`
`
`
`iii
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 5 of 150 PageID #: 9263
`
`1.
`
`2.
`
`Plaintiffs’ Introduction ..............................................................61
`
`Defendants’ Introduction ..........................................................62
`
`A.
`
`“Following Fermentation” (Claims 5, 8) ............................................63
`
`1.
`
`2.
`
`Plaintiffs’ Opening Position ......................................................63
`
`Defendants’ Answering Position ..............................................67
`
`a.
`
`b.
`
`Amgen’s Answering Position .........................................67
`
`Samsung’s Answering Position ......................................72
`
`3.
`
`Plaintiffs’ Reply Position ..........................................................76
`
`a.
`
`b.
`
`Plaintiffs’ Reply to Amgen’s Position ............................76
`
`Plaintiffs’ Reply to Samsung’s Position .........................80
`
`4.
`
`Defendants’ Sur-Reply Position ...............................................82
`
`a.
`
`b.
`
`Amgen’s Sur-Reply Position ..........................................82
`
`Samsung’s Sur-Reply Position .......................................83
`
`B.
`
`“Pre-Harvest [Culture Fluid]” (Claims 5, 8) .......................................84
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ......................................................84
`
`Samsung’s Answering Position ................................................86
`
`Plaintiffs’ Reply Position ..........................................................87
`
`Samsung’s Sur-Reply Position .................................................88
`
`IV. U.S. PATENT NOS. 8,512,983 AND 9,714,293 ..........................................88
`
`1.
`
`2.
`
`Plaintiffs’ Introduction ..............................................................88
`
`Defendants’ Introduction ..........................................................90
`
`
`
`iv
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 6 of 150 PageID #: 9264
`
`A.
`
`“A Glutamine-Free Production Culture Medium” (’983 Claims
`2, 19; ’293 Claims 72, 73) ...................................................................91
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ......................................................91
`
`Defendants’ Answering Position ..............................................95
`
`Plaintiffs’ Reply Position ........................................................102
`
`Defendants’ Sur-Reply Position .............................................110
`
`V. U.S. Patent No. 7,485,704 PATENT ...........................................................113
`
`A.
`
`“About 18°C” (Claims 6, 12) ............................................................113
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ....................................................113
`
`Samsung’s Answering Position ..............................................117
`
`Plaintiffs’ Reply Position ........................................................118
`
`Samsung’s Sur-Reply Position ...............................................120
`
`B.
`
`“Performing Subsequent Purification Of Compositions
`Comprising Said Protein By Protein A Affinity
`Chromatography At A [Temperature Range]” (Claims 6, 12) .........120
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ....................................................120
`
`Samsung’s Answering Position ..............................................122
`
`Plaintiffs’ Reply Position ........................................................122
`
`Samsung’s Sur-Reply Position ...............................................123
`
`VI. U.S. PATENT NO. 7,390,660 .....................................................................123
`
`A.
`
`“Wherein Said Citric Acid Or Citrate Is Maintained At A
`Concentration Of About 1 To 50 mmol/L During Cultivation”
`And “Is Not Bound In A Chelate Complex With Iron Or
`Another Transition Metal Ion” (Claim 3, 6) .....................................123
`v
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 7 of 150 PageID #: 9265
`
`1.
`
`2.
`
`3.
`
`4.
`
`Plaintiffs’ Opening Position ....................................................124
`
`Samsung’s Answering Position ..............................................127
`
`a.
`
`b.
`
`“not bound” ...................................................................127
`
`“about 1 to 50 mmol/l” .................................................129
`
`Plaintiffs’ Reply Position ........................................................130
`
`Samsung’s Sur-Reply Position ...............................................133
`
`a.
`
`b.
`
`“not bound” ...................................................................133
`
`“about 1 to 50 mmol/l” .................................................134
`
`
`
`
`
`vi
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 8 of 150 PageID #: 9266
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Abtox, Inc. v. Exitron Corp.,
`122 F.3d 1019 (Fed. Cir. 1997), opinion amended on reh’g, 131
`F.3d 1009 (Fed. Cir. 1997) ................................................................................. 12
`
`Alfred E. Mann Found. for Sci. Research v. Cochlear Corp.,
`841 F.3d 1334 (Fed. Cir. 2016) .................................................................... 59, 60
`
`Allergan Sales, LLC v. Lupin Ltd.,
`2013 WL 4519609 (E.D. Tex. Aug. 21, 2013) ................................................... 31
`
`Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc. v. Mut. Pharm. Co.,
`384 F.3d 1333 (Fed. Cir. 2004) .................................................................... 20, 29
`
`August Tech. Corp. v. Camtek, Ltd.,
`655 F.3d 1278 (Fed. Cir. 2011) .............................................................. 13, 22, 29
`
`Baran v. Med. Device Techs., Inc.,
`616 F.3d 1309 (Fed. Cir. 2010) .................................................................... 29, 30
`
`Berkheimer v. HP Inc.,
`881 F.3d 1360 (Fed. Cir. 2018) .................................................................... 41, 43
`
`Biogen Idec, Inc. v. GlaxoSmithKline LLC,
`713 F.3d 1090 (Fed. Cir. 2013) ..................................................70, 129, 133, 134
`
`Boston Sci. Corp. v. Cook Inc.,
`187 F. Supp. 3d 249, 275-76 (D. Mass. 2016) ................................................... 15
`
`C.R. Bard, Inc. v. U.S. Surgical Corp.,
`388 F.3d 858 (Fed. Cir. 2004) ...................................................................... 17, 72
`
`CAE Screenplates Inc. v. Heinrich Fiedler GmbH,
`224 F.3d 1308 (Fed. Cir. 2000) .......................................................................... 51
`
`Chicago Bd. Options Exch., Inc. v. Int’l Sec. Exch., LLC,
`677 F.3d 1361 (Fed. Cir. 2012) .................................................................... 57, 60
`
`
`
`vii
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 9 of 150 PageID #: 9267
`
`Convolve, Inc. v. Compaq Computer Corp.,
`812 F.3d 1313 (Fed. Cir. 2016) .............................................................. 12, 13, 22
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ...................................................................................... 114
`
`Datamize, LLC v. Plumtree Software, Inc.,
`417 F.3d 1342 (Fed. Cir. 2005) .......................................................................... 71
`
`Depomed, Inc. v. Purdue Pharma L.P.,
`No. 13-571 (MLC)(TJB), 2017 WL 1319818 (D.N.J. Apr. 6, 2017) ................. 15
`
`Desenberg v. Google, Inc.,
`392 F. App’x 868 (Fed. Cir. 2010) ............................................................... 54, 60
`
`Ecolab, Inc. v. FMC Corp.,
`569 F.3d 1335 (Fed. Cir. 2009) ................................................................ 132, 134
`
`Ferring B.V. v. Watson Labs., Inc.-Fla.,
`764 F.3d 1382 (Fed. Cir. 2014) ................................................................ 115, 125
`
`Geneva Pharm., Inc. v. GlaxoSmithKline PLC,
`349 F.3d 1373 (Fed. Cir. 2003) .......................................................................... 75
`
`GPNE Corp. v. Apple Inc.,
`830 F.3d 1365 (Fed. Cir. 2016) .......................................................................... 60
`
`Haemonetics Corp. v. Baxter Healthcare Corp.,
`607 F.3d 776 (Fed. Cir. 2010) ...................................................................... 13, 22
`
`Halliburton Energy Servs., Inc. v. M-I LLC,
`514 F.3d 1244 (Fed. Cir. 2008) .......................................................................... 75
`
`Int’l Test Sols., Inc. v. Mipox Int’l Corp.,
`No. 16-cv-00791-RS, 2017 WL 1367975 (N.D. Cal. Apr. 10, 2017) ................ 41
`
`Interval Licensing LLC v. AOL, Inc.,
`766 F.3d 1364 (Fed. Cir. 2014) .............................................................. 46, 48, 49
`
`Karlin Tech. Inc. v. Surgical Dynamics, Inc.,
`177 F.3d 968 (Fed. Cir. 1999) .......................................................... 20, 23, 30, 31
`
`
`
`viii
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 10 of 150 PageID #:
`9268
`
`Kustom Signals, Inc. v. Applied Concepts, Inc.,
`264 F.3d 1326 (Fed. Cir. 2001) .................................................................... 10, 22
`
`Liberty Ammunition, Inc. v. United States,
`835 F.3d 1388 (Fed. Cir. 2016) .................................................................... 41, 43
`
`Mantech Envtl. Corp. v. Hudson Envtl. Servs., Inc.,
`152 F.3d 1368 (Fed. Cir. 1998) .......................................................................... 55
`
`Meds. Co. v. Mylan, Inc.,
`853 F.3d 1296 (Fed. Cir. 2017) .......................................................................... 32
`
`Multiform Desiccants, Inc. v. Medzam, Ltd.,
`133 F.3d 1473 (Fed. Cir. 1998) .......................................................................... 55
`
`Norian Corp. v. Stryker Corp.,
`432 F.3d 1356 (Fed. Cir. 2005) .......................................................................... 12
`
`Nystrom v. TREX Co.,
`424 F.3d 1136 (Fed. Cir. 2005) .......................................................................... 56
`
`Omega Eng’g, Inc. v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003) .......................................................................... 53
`
`Pall Corp. v. Micron Separations, Inc.,
`66 F.3d 1211 (Fed. Cir. 1995) .......................................................................... 115
`
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) .......................................................................... 11
`
`Pharmastem Therapeutics, Inc. v. Viacell, Inc.,
`No. 02-148-GMS, 2003 WL 124149 (D. Del. Jan. 13, 2003) ............................ 26
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ................................................................ 105, 109
`
`Poly-Am., L.P. v. API Indus., Inc.,
`839 F.3d 1131 (Fed. Cir. 2016) .................................................................. 81, 109
`
`Rexnord Corp. v. Laitram Corp.,
`274 F.3d 1336 (Fed. Cir. 2001) .................................................................... 19, 28
`
`
`
`ix
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 11 of 150 PageID #:
`9269
`
`Route1 Inc. v. AirWatch LLC,
`2018 WL 3574873 (D. Del. July 25, 2018) ........................................................ 29
`
`Saffran v. Johnson & Johnson,
`712 F.3d 549 (Fed. Cir. 2013) .......................................................................... 134
`
`SkinMedica, Inc. v. Histogen Inc.,
`727 F.3d 1187 (Fed. Cir. 2013) .................................................................... 10, 22
`
`Telcordia Techs., Inc. v. Cisco Sys., Inc.,
`612 F.3d 1365 (Fed. Cir. 2010) .......................................................................... 99
`
`Texas Instruments Inc. v. ITC,
`988 F.2d 1165 (Fed. Cir. 1993) .......................................................................... 51
`
`Thorner v. Sony Comput. Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 29
`
`TIP Systems, LLC v. Phillips & Brooks/Gladwin, Inc.,
`529 F.3d 1364 (Fed. Cir. 2008) ........................................................................ 128
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) .......................................................................... 103
`
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ........................................................ 10, 22, 28, 29
`
`
`
`x
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 12 of 150 PageID #:
`9270
`
`Pursuant to the Court’s Scheduling Order in the above-captioned cases,
`
`Plaintiffs Genentech, Inc. and City of Hope (“Plaintiffs”) and Defendants Amgen
`
`Inc. (“Amgen”) and Samsung Bioepis Co., Ltd. (“Samsung” and collectively with
`
`Amgen, “Defendants”) submit the following Joint Claim Construction Brief.
`
`AGREED-UPON CONSTRUCTIONS
`
`The chart below sets forth the terms and agreed-upon constructions for the
`
`Agreed-Upon Construction
`wherein the breast cancer cells from
`the human subject have been found
`to express ErbB2 protein at a 0 or 1+
`level by any immunohistochemistry
`test
`
`The preamble is limiting
`
`The preamble is limiting
`
`patents asserted in these litigations.
`
`Claim Term and Claim
`“wherein the breast cancer cells from the
`human subject have been found to have a 0
`or 1+ score of ErbB2 protein expression by
`immunohistochemistry”
`
`U.S. Patent No. 7,993,834, Claims 2, 5
`
`“A method of identifying and treating a
`breast cancer patient disposed to respond
`favorably to a HER2 antibody,
`huMAb4D5-8”
`
`U.S. Patent No. 8,076,066, Claims 2, 6
`
`“A method for the prevention of the
`reduction of a disulfide bond in an antibody
`expressed in a recombinant host cell”
`
`U.S. Patent No. 8,574,869, Claims 5, 8
`
`
`1
`
`
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 13 of 150 PageID #:
`9271
`
`Claim Term and Claim
`“sparging”
`
`U.S. Patent No. 8,574,869, Claims 5, 8
`
`“harvested culture fluid”
`
`U.S. Patent No. 8,574,869, Claims 5, 8
`
`“eluting the mixture at a gradient of about
`0-1 M of an elution salt”
`
`U.S. Patent No. 6,620,918, Claims 5, 7
`
`“A method for reducing glucose
`consumption during cultivation”
`
`U.S. Patent No. 7,390,660, Claim 3
`
`“A method for reducing lactate production
`during cultivation”
`
`U.S. Patent No. 7,390,660, Claim 6
`
`
`
`
`Agreed-Upon Construction
`bubbling of a gas into a liquid
`
`
`culture fluid that has been harvested
`
`eluting the mixture starting at a first
`concentration between 0 and 1 M of
`an elution salt and ending at a second
`higher concentration between 0 and 1
`M of the elution salt
`
`The preamble is limiting
`
`The preamble is limiting
`
`DISPUTED CONSTRUCTIONS
`
`The parties’ respective positions on disputed claim terms are set forth below.
`
`In view of the settlement and dismissal of Genentech, Inc. v. Celltrion, Inc., No.
`
`18-cv-95-CFC (consolidated), certain disputed claim terms specific to that case
`
`that were addressed in the Joint Claim Construction Chart are no longer at issue.
`
`In addition, subsequent to submitting the Joint Claim Construction Chart, the
`
`
`
`2
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 14 of 150 PageID #:
`9272
`
`parties have agreed upon a claim construction for the term “wherein the breast
`
`cancer cells from the human subject have been found to have a 0 or 1+ score of
`
`ErbB2 protein expression by immunohistochemistry” in U.S. Patent No. 7,993,834,
`
`as reflected above.
`
`I.
`
`U.S. PATENT NOS. 6,627,196, 7,371,379, AND 10,160,811
`
`1.
`
`Plaintiffs’ Introduction
`
`Trastuzumab, the active ingredient in Genentech’s drug Herceptin, was
`
`initially approved by the FDA in August 1998 with a weekly dosing regimen. The
`
`’196, ’379, and ’811 method-of-treatment patents reflect the further discovery that
`
`trastuzumab could be administered less frequently without compromising safety or
`
`efficacy. JA00000012(’196 patent,1 6:20-31).2 In particular, the patents teach how
`
`to administer the drug in ways that allow for longer intervals between doses while
`
`still maintaining efficacy. JA00000012(6:31-46); JA00000026(34:20-23). For
`
`example, claim 7 of the ’811 patent recites a method of administering an initial
`
`dose of 8 mg/kg trastuzumab followed by subsequent doses of 6 mg/kg every three
`
`weeks. JA00005411(57:51-38).
`
`
`1
`The ’196, ’379, and ’811 patents contain identical disclosures. For
`convenience, Plaintiffs cite to the ’196 specification.
`
`2
`“JA000000___” refers to the Joint Claim Construction Chart Appendix C.
`18-cv-924, D.I. 60; 18-cv-1363, D.I. 48.
`
`
`
`3
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 15 of 150 PageID #:
`9273
`
`2.
`
`Defendants’ Introduction
`
`These “Dosing Patents” share a specification and describe methods of
`
`treating cancer using an anti-ErbB2 antibody, such as trastuzumab (Herceptin),
`
`using a schedule involving an initial dose followed by maintenance doses
`
`administered less frequently than weekly. Before the original application was filed
`
`in August 1999, trastuzumab was FDA-approved and marketed for administration
`
`using an initial dose of 4 mg/kg followed by weekly maintenance doses of 2
`
`mg/kg. Declaration of Michelle S. Rhyu in Support of Defendants’ Claim
`
`Construction Brief (“Rhyu Decl.”) Ex. 1 (Herceptin 1998 Label).
`
`A.
`
`“An Initial Dose” (’196 Claims 11, 22; ’379 Claims 11, 21; ’811
`Claims 6, 7)
`
`Plaintiffs’ Proposal
`Initial single dose or initial
`series of doses
`
`Amgen’s Proposal
`The first dose of the
`claimed antibody given to
`the patient as part of a
`treatment regimen
`
`Samsung’s Proposal
`The first dose of the
`claimed antibody given to
`the patient as part of a
`treatment regimen, also
`known as the loading
`dose
`
`
`
`
`
`1.
`
`Plaintiffs’ Opening Position
`
`The parties have two key disputes:
`
`1.
`
`Can “an initial dose” be a series of doses or a single dose as
`
`Plaintiffs propose, or must it be a single dose as Defendants
`
`propose?
`
`4
`
`

`

`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 16 of 150 PageID #:
`9274
`
`2.
`
`Is “an initial dose” necessarily a “loading dose” as only Samsung
`
`contends?
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`Each of these disputes should be resolved in Plaintiffs’ favor.
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`First, the claim language of the ’196 patent confirms that “an initial dose”
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`can include more than one dose, i.e., a series of doses. Specifically, claim 16 of
`
`the ’196 patent recites “administering to the patient an initial dose of the antibody,
`
`wherein the initial dose is a plurality of doses.” JA00000038. A “plurality of
`
`doses” is more than one dose, which is reflected in Plaintiffs’ construction. In
`
`comparison, Defendants’ proposed construction is irreconcilable with how “an
`
`initial dose” is used in the claims themselves, since their construction excludes a
`
`plurality of doses.
`
`Moreover, consistent with claim 16’s recitation of a “plurality of doses,” the
`
`patentee defined “an initial dose” to include a “series of doses.” For example, the
`
`specification states that “[t]he initial dose may be one or more administrations of
`
`drug.” JA00000011(4:56-60). The specification also describes embodiments
`
`“[w]here the initial dose is a series of doses.” JA00000019(19:34-37). See also
`
`JA00000031(44:57-65) (“[T]he front loading initial dose is a series of intravenous
`
`or subcutaneous injections….”). To encompass the full scope of the term as used
`
`in the patents’ claims and specification, the term “an initial dose” should be
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`construed to encompass either a single dose or a series of doses.
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`Second, no evidence supports limiting “an initial dose” to a “loading dose,”
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`as proposed by Samsung (and no other party). “An initial dose” can be a loading
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`dose, which the specification defines as “an initially higher dose followed by the
`
`same or lower doses at intervals.” JA00000019(19:19-21). But the specification
`
`also makes clear that “an initial dose” need not be a “loading dose”—for example,
`
`where the initial dose amount is lower than the subsequent dose amounts.
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`JA00000031(44:57-65) (total initial dose of more than 4 mg/kg, subsequent doses
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`of 6 mg/kg); JA00000012(5:40-43) (initial dose series of 1 mg/kg a day for three
`
`days, subsequent doses of 6 mg/kg). In short, the intrinsic record provides no basis
`
`to read the separate concept of a “loading dose” into this claim term. Accordingly,
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`the Court should reject Samsung’s attempt to narrow the claims by requiring that
`
`an “initial dose” always be a “loading dose.”
`
`2.
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`Defendants’ Answering Position
`
`a.
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`Amgen’s Answering Position
`
`Amgen asserts that “an initial dose” means “the first dose” as opposed to a
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`series of doses. Genentech’s construction is inconsistent with the intrinsic
`
`evidence and the common use of this term by a POSA. To a POSA, “an initial
`
`dose” means a single first dose given to a patient who is beginning new treatment.
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`This first dose is distinct from subsequent doses because the initial dose is given
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`
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`6
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`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 18 of 150 PageID #:
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`with the goal of establishing an efficacious level of the drug in the patient, while
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`subsequent doses are designed to maintain that level.
`
`The claims and specification repeatedly distinguish treatment regimens
`
`having a single initial dose from those having a series of initial doses. Claim 1 and
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`its dependent claims cover only the single initial dose embodiment, while claim 16
`
`covers the alternative series of initial doses. Genentech’s insistence that “an initial
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`dose” must have the same meaning in claims 1 and 16 ignores case law. Where, as
`
`here, the specification and claims provide distinct alternative embodiments of a
`
`term, it is proper to construe claim 1 as the single initial dose embodiment and
`
`claim 16 as the embodiment requiring a series of doses. Finally, Genentech’s
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`construction is indefinite, because it destroys any distinction between the “initial
`
`dose” and “subsequent doses” recited in the claims.
`
`i.
`
`“An initial dose” means “the first dose.”
`
`The plain and ordinary meaning of “an initial dose,” consistent with the
`
`teachings of the specification, is a single first dose given to a patient as part of a
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`treatment regimen. Declaration of John A. Glaspy, M.D. (“Glaspy”) ¶¶33-36, 44.
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`Consistent with this, the specification uses “first dose” synonymously with “an
`
`initial dose.” See also Glaspy ¶36.
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`
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`7
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`JA00000012(6:54-61)
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`JA00000012(6:22-28)
`
`“the invention provides a method for the
`treatment of cancer in a human patient
`… comprising administering
`to
`the
`patient an
`initial dose of at
`least
`approximately 5 mg/kg of the anti-ErbB
`antibody; and administering
`to
`the
`patient a plurality of subsequent doses
`of the antibody ….” (emphasis added)
`
`“[T]he invention provides a method for
`the treatment of cancer … comprising
`administering to the patient first dose of
`an anti-ErbB2 antibody followed by at
`least one subsequent dose of
`the
`antibody ….”
`
`Other intrinsic evidence also uses “initial” to mean “first.” For example, the
`
`prior art 1998 Herceptin label refers to the first 4 mg/kg dose as “the initial loading
`
`dose.” Rhyu Decl. Ex. 1 (Herceptin 1998 Label)3; Glaspy ¶¶28-29, 34. Indeed,
`
`the specification and file history both refer to the 4 mg/kg administered in the prior
`
`art dosing regimen as the initial loading dose. See JA00000011(3:61-65) (“The
`
`recommended initial loading dose for HERCEPTIN® is 4 mg/kg .… [t]he
`
`recommended weekly maintenance dose is 2 mg/kg .…”) (emphasis added); see
`
`also JA00000697; see also Glaspy ¶¶28-29, 34.
`
`
`3 This usage persists in the current Herceptin label. Rhyu Decl. Ex. 3 (Herceptin
`2018 Label).
`
`
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`8
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`ii.
`
`The specification distinguishes between (1) “an
`initial dose” and (2) “initial doses” or “series of
`doses.”
`
`Dosing regimens in which the initial dose is given to the patient as a single
`
`administration are described throughout the specification. But the specification
`
`also describes regimens in which the initial dose is divided into a series of doses.
`
`For example, where a clinician might be concerned that a single large initial dose
`
`could be toxic, the initial dose might be administered as a series of smaller doses
`
`given in succession. See, e.g., JA00000012(5:40-44) (“In another embodiment, the
`
`invention includes initial doses . . . on each of days 1, 2 and 3 .…”); see also
`
`Glaspy ¶40.
`
`Critically for the dispute here, the specification consistently uses the
`
`disjunctive term “or” to distinguish a single initial dose from a series of initial
`
`doses:
`
`“The present invention concerns the discovery that an early attainment
`of an efficacious target trough serum concentration by providing an
`initial dose or doses of anti-ErbB2 antibodies followed by subsequent
`doses of equal or smaller amounts of antibody (greater front loading)
`is more efficacious than conventional treatments.”
`
`JA00000011(4:21-26) (emphasis added). This usage pervades the patent:
`
`“[a]ccording to the present invention, front loading is achieved by an initial dose
`
`or doses delivered over three weeks or less that causes the animal’s or patient’s
`
`serum concentration to reach a target serum trough concentration. Preferably, the
`
`
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`9
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`Case 1:18-cv-01363-CFC Document 78 Filed 03/22/19 Page 21 of 150 PageID #:
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`initial front loading dose or series of doses.” JA00000019(19:24-29) (emphasis
`
`added); see also JA00000011(4:38-40 (“Preferably, the initial dose (or doses) as
`
`well as
`
`the subsequent maintenance dose or doses are administered
`
`subcutaneously.”) (emphasis added)). Indeed, the specification expressly describes
`
`a regimen involving multiple “initial doses” as an “alternative regimen” to those
`
`regimens reciting a single initial dose. JA00000026(34:27-31) (emphasis added).
`
`These uses of the word “or” mean the two embodiments are distinct
`
`alternatives. See, e.g., Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d
`
`1272, 1280 (Fed. Cir. 2017) (“[u]si